Forester, Joseph P. DO; McWhorter, David L. PhD
Medical students seem to be a logical and ideal participant pool for medical education research studies. They are directly affected by the quality of medical instruction, which presumably would make them willing and reliable participants. In many instances, medical students are readily accessible, thus making the administration of educational research projects straightforward. However, these same advantages that make medical students desirable participants may also make them vulnerable.1
Because medical students are a captive population in the medical school community, their autonomy to freely consent to participate in research may be compromised.1 Consequently, some students may feel coerced to participate because of a faculty member’s position of authority.2 Other medical students may participate, believing it will result in better grades, letters of recommendation, and/or other favors.2
Other issues are involved when medical students are research participants. Students’ confidentiality may be compromised, especially considering the close community of a medical school. Additionally, medical students may not know their input is being used for research purposes.3
To protect the rights of medical students who are participants in research, Institutional Review Boards (IRBs) evaluate all human participant research protocols, including tools for recruiting participants, in an effort to comply with U.S. Food and Drug Administration regulations.4 The specific roles of IRBs and the federal policy for protecting human participants are cited under Title 45, part 46 of the Code for Federal Regulations.5 Research programs at Duke University, Johns Hopkins University, the University of Pennsylvania, Virginia Commonwealth University, and others have been shut down in the past by the federal government for days to months because of concerns regarding the protection of human participants.6 Consequently, IRBs across the United States have become increasingly sensitive to protecting human participants.6 Whether medical students need unique protection is disputed in the literature. Some universities either prohibit students’ participation in research or severely limit participation to projects involving minimal risks and time.1 Others have cited such safeguards as paternalistic and overprotective.2,3,7
Published opinions agree that medical students are able to comprehend study procedures, evaluate protocol risks, and understand the importance of research.1–3,7 These attributes suggest that medical students are able to give informed consent to participate in medical education research, which may not be possible to achieve with other volunteers.1 However, the same published data suggest that medical students’ ability to give free consent as research participants may be compromised due to perceived subordination to medical school faculty.
Using the Educational Resources Information Center (ERIC) and Medline, we found no published data on medical students’ perceived value of medical education research or their reasons for participating in medical education studies. We undertook this study to determine medical students’ perceptions of medical education research and their role as research participants; and whether published opinions about why medical students participate in medical education research are accurate. We addressed these two research questions by administering a questionnaire in 2003–04 to first- through fourth-year students at Kansas City University of Medicine and Biosciences College of Osteopathic Medicine (KCUMB-COM), formerly the University of Health Sciences College of Osteopathic Medicine, in Kansas City, Missouri. Grant funding was not required to conduct this investigation.
In this study, we used a questionnaire of eight close-ended questions that asked students for Yes/No responses and the student’s year of medical training. During the creation of the questionnaire, we prepared a protocol according to KCUMB-COM IRB guidelines that subsequently underwent a full review. (See Table 1 for questions.)
Once we obtained IRB approval, we placed the questionnaire online at <http://www.formsite.com> and tested the hyperlink before contacting the students as a data quality control measure. Placing the questionnaire online safeguarded the students’ anonymity and provided the study internal and external validity. A general e-mail invitation to participate in the study was sent to all 896 first- through fourth-year students enrolled at KCUMB-COM in 2003–04 and included a description of the study and a hyperlink to the online questionnaire.
Sampling of all enrolled KCUMB-COM students permitted us to investigate whether the phase of medical training (i.e., preclinical and clinical) would influence students’ responses to the questionnaire. Preclinical students were first- (n = 230) and second-year (n = 220) students who were on campus completing their basic science coursework. Clinical students were third- (n = 238) and fourth-year (n = 208) students who were off campus completing clinical clerkships in various settings throughout the United States. Based on the literature, we hypothesized that the number of completed questionnaires and the responses to questions might differ between students on the KCUMB-COM campus (i.e., preclinical students; n = 450) and students off the KCUMB-COM campus (i.e., clinical students; n = 446).
We gave students one month to complete the online questionnaire. During the data collection period, the KCUMB-COM IRB granted a separate expedited approval for us to e-mail students several reminder invitations to participate in the study. These e-mail reminders were sent during the third and fourth weeks of data collection. After one month, completed questionnaires were downloaded from the Web site into a standard spreadsheet program.
We initially tallied the “yes” and “no” responses to the eight questions by year of training (e.g., first-year, second-year etc.,), and subsequently converted responses into numbers and percentages based on the total number of responses for each class (e.g., 125 “yes” responses out of a total of 129 responses equals 97%). We conducted a chi-square analysis using SigmaStat 3.0 (SPSS, Inc., Chicago, Illinois) to statistically compare differences in response rates among first- through fourth-year students, and questionnaire responses between preclinical and clinical students. This nonparametric statistical test was appropriate given the data collected (i.e., categorical responses to a questionnaire). Observations were independent and categories mutually exclusive, providing qualitative data reliability and validity. For the two (i.e., preclinical and clinical groups)-by-two (i.e., “yes” and “no” responses) contingency tables (i.e., each of the eight survey questions), we used a Yates’ correction for continuity. We set an alpha level for significance at .05.
One hundred and twenty-nine first-year students (56.09%), 156 second-year students (70.91%), 140 third-year students (58.82%), and 99 fourth-year students (47.60%) completed the questionnaire. A total of 524 students (58.5%) completed the questionnaire. A total of 285 preclinical students (63.33%) and 239 clinical students (53.59%) completed the questionnaire.
Chi-square analysis did not show a significant difference in response rate between first-, second-, third-, and fourth-year students (p = .144). Additionally, it did not show a significant difference in the response rates between preclinical and clinical students (p = .094).
The total number of “yes” and “no” responses to the eight questions and the corresponding percentages tallied and calculated for first- through fourth-year students are shown in Table 1. We used these data to tally “yes” and “no” responses and resultant percentages for both preclinical and clinical students. (see Table 2)
To investigate whether the “yes” and “no” responses of preclinical medical students differed significantly from those of clinical medical students, we conducted a chi-square analysis for each of the eight questions. Table 2 shows the results of this analysis.
Our primary reasons for conducting this study were to better understand medical students’ perceptions of medical education research and their role as research participants; and whether published opinions about why medical students participate in medical education research are accurate. To address these two research questions, we designed a descriptive study in which we used a questionnaire. An obvious limitation of this method was that the results are what students said they believed.
We found, however, no directly related published studies from which to make research hypotheses based on scientific merit. Existing data provide only opinions about why medical students participate in research.1–3 Thus, our research hypotheses for this investigation are based on KCUMB-COM students’ behaviors.
Because the quality of our students’ medical education may be directly affected by medical education research, we hypothesized that a majority of medical students would affirm its importance. Our results show that 487 of the 524 participants (93%) believed that medical education research should be conducted at KCUMB-COM in an effort to improve their medical training. We speculate that the 36 students (7%) who responded “no” to this question may either have not understood the practical implications of medical education research and/or may not have believed the results of medical education research would be incorporated in their medical training.
Significantly more preclinical medical students indicated that medical education research should be conducted than did clinical medical students. Although this finding was statistically significant (p = .035), the difference between the two groups did not appear meaningful (95% versus 90%). Perhaps the formal classroom and laboratory settings of preclinical medical students and the “on-the-job” training environment of clinical students influenced their responses.
While 488 (93%) medical students agreed that medical education research should be conducted, only 208 of the 524 students (40%) indicated a vested interest in participating. This seemingly contradictory finding suggests that medical students want the potential benefits of medical education research without having to be directly involved. Although our study design did not allow us to provide an objective explanation for this finding, we offer two reasons: medical students may have believed they lacked sufficient time to participate; and/or they may not have thoroughly understood the expectations of participating in medical education research.
When we compared the responses of preclinical medical students to those of clinical medical students, significantly more first- and second-year students [130 (46%)] expressed a vested interest in participating compared to third- and fourth-year students [78 (33%); p = .003]. We believe this finding may have been due to preclinical medical students receiving more formal educational guidance than clinical medical students. Our preclinical medical students attend lectures, often with prepared lecture notes. Additionally, our preclinical faculty advise students as to which texts to buy and which pages to read, and maintain regular office hours to meet with and answer students’ questions. Conversely, third- and fourth-year medical students are expected to perform more independently. Thus, the inherent difference between the preclinical and clinical educational settings may explain why significantly fewer clinical students expressed a vested interest to participate in medical education research.
Our second research question was to assess published views and opinions as to why medical students participate in research. According to The Office for Human Research Protections, U.S. Department of Health and Human Services:
Students may volunteer to participate out of a belief that doing so will place them in good favor with faculty (e.g., that participating will result in receiving better grades, recommendations, employment, or the like), or that failure to participate will negatively affect their relationship with the investigator or faculty (i.e., by seeming ‘uncooperative,’ not part of the scientific community).1, section J, paragraph 9
Christakis wrote, “… a medical student is less free than a random adult to refuse the request of a faculty investigator to be a research subject.”2, p.2 Shannon noted, “… medical school students can be seen as a type of captive population, a status that could not only decrease their autonomy but also expose them to unreasonable demands for the time.”3, p.4 Collectively, we used these published data to formulate questions 3 through 8.
Based on our experience of students’ behaviors, we disagree with published opinions and views of why medical students participate in medical education research.1–3 Our findings support our hypothesis that medical students do not feel coerced to participate in medical education research studies because of a faculty member’s position of authority. However, when we compared the responses of preclinical medical students to those of clinical medical students for this question, significantly more third- and fourth-year students felt coerced to participate [33 (14%)] than did first- and second-year students [14 (5%)](p < .001). This finding suggests that our clinical medical students felt a greater need to cooperate with authority figures than did preclinical students. Clinical medical students must determine and abide by subjective expectations of various physicians to successfully complete clinical rotations. On the other hand, preclinical students are required to pass computer-graded, objective quizzes and examinations to make satisfactory progress in their first two years of medical training.
Contrary to published data,1–3 we hypothesized that medical students would not believe their participation in medical education research would result in better grades, letters of recommendation, and/or other favors. Our results confirm this hypothesis. A total of 398 students, more than three-quarters of our respondents, did not believe they would receive better grades, recommendations, or other favors for participating in medical education studies. Sixty-eight (28%) third- and fourth-year medical students believed that they would receive better grades, recommendations, or other favors for participating in medical education research compared to 58 (20%) first- and second-year students (p = .040). This finding is consistent with our earlier supposition regarding the differences between preclinical and clinical training.
We hypothesized that if medical students were asked to participate in medical education studies voluntarily and anonymously, a minority of them would be concerned with their confidentiality. Our results support this hypothesis. A total of 468 (89%) students were not concerned with their confidentiality if their participation was voluntary and anonymous. However, 298 (57%) students reported a concern for their confidentially if their participation was not anonymous.
Christakis reported, “… students are also especially susceptible to certain other abuses, such as being used as subjects in behavioral research involving deception.” 2, p.3 We asked medical students, if they would feel violated, if their voluntary input to medical education-related issues was subsequently used for medical education research purposes. A total of 401 (96%) said No. When we compared preclinical and clinical students’ responses to this question, we found no significant difference (p = .390).
Some universities have either prohibited students’ participation in research studies or have severely limited participation to research that involves minimal risk and time.1 Others have regarded such safeguards as paternalistic and overprotective.2,3,7 We asked our students if they believed special protections were needed for students participating in medical education research. To help clarify the meaning of “special protections,” we gave “student representation on the Institutional Review Board” as an example. A total of 326 students (62%) responded “yes” to this item. This question had two limitations: “special protections” may have meant different things to students, and the example given, “student representation on the Institutional Review Board” may have biased the students’ responses. For this item, we found no significant difference between the responses of preclinical students and clinical students (p = .448).
Our study showed that medical students want medical education research conducted in an effort to improve their education. Medical students may be viewed as “stakeholders” within a medical school community. From a practical standpoint, medical school decisionmakers may want to embrace their “stakeholders’” value of medical education research by recognizing and/or prioritizing it within a university’s mission.
Our study also has a theoretical implication. In contrast to published opinions and views,1–3 our students did not feel coerced to participate in medical education studies because of faculty members’ position of authority and they did not believe their participation would result in better grades, recommendations, and/or other favors. Our medical students were not concerned with their confidentiality as long as their participation in medical education studies was voluntary and anonymous. Additionally, our medical students did not feel violated if their responses to medical education questions were used for medical education research purposes, presumably as long as their anonymity was preserved. Collectively, these findings have practical significance. IRB “protection” of medical students who participate in medical education studies via a full review may be both unnecessary and inappropriate.
In conclusion, we recommend avenues for future investigation. Because our results reflected the views of over 500 medical students from only one osteopathic medical school, we recommend the study be replicated in other osteopathic and allopathic medical schools. In addition, different and/or additional questions about medical students’ roles as participants in medical education research should be formulated. Lastly, we recommend an investigation into the number of medical school IRBs that require medical education studies to undergo the same level of scrutiny as clinical trials (i.e., full review).
The authors would like to thank Ms. Nancy L. Stroud, KCUMB-COM Interlibrary Loan Specialist, for retrieving, copying, and compiling manuscript references.
The opinions or assertions contained in this article are the private views of the authors and do not reflect the opinions of the San Antonio Military Pediatric Center, the U.S. Department of Defense, the United States Air Force, or Kansas City University of Medicine and Biosciences College of Osteopathic Medicine.